ES2185452B2 - PHARMACEUTICAL COMPOSITION OF FLUOXETINE IN A DISPERSABLE COATED TABLET AND ITS MANUFACTURING PROCESS. - Google Patents
PHARMACEUTICAL COMPOSITION OF FLUOXETINE IN A DISPERSABLE COATED TABLET AND ITS MANUFACTURING PROCESS.Info
- Publication number
- ES2185452B2 ES2185452B2 ES200001952A ES200001952A ES2185452B2 ES 2185452 B2 ES2185452 B2 ES 2185452B2 ES 200001952 A ES200001952 A ES 200001952A ES 200001952 A ES200001952 A ES 200001952A ES 2185452 B2 ES2185452 B2 ES 2185452B2
- Authority
- ES
- Spain
- Prior art keywords
- fluoxetine
- manufacturing process
- pharmaceutical composition
- coated tablet
- dispersable
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 229960002464 fluoxetine Drugs 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- RTHCYVBBDHJXIQ-UHFFFAOYSA-N N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine Chemical compound C=1C=CC=CC=1C(CCNC)OC1=CC=C(C(F)(F)F)C=C1 RTHCYVBBDHJXIQ-UHFFFAOYSA-N 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 3
- RTHCYVBBDHJXIQ-MRXNPFEDSA-N (R)-fluoxetine Chemical compound O([C@H](CCNC)C=1C=CC=CC=1)C1=CC=C(C(F)(F)F)C=C1 RTHCYVBBDHJXIQ-MRXNPFEDSA-N 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 239000007888 film coating Substances 0.000 abstract 2
- 238000009501 film coating Methods 0.000 abstract 2
- 239000003826 tablet Substances 0.000 abstract 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000013543 active substance Substances 0.000 abstract 1
- 230000001430 anti-depressive effect Effects 0.000 abstract 1
- 239000000935 antidepressant agent Substances 0.000 abstract 1
- 229940005513 antidepressants Drugs 0.000 abstract 1
- 239000007919 dispersible tablet Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Composición farmacéutica de fluoxetina en comprimido dispersable recubierto y su proceso de fabricación, del tipo de composición empleada como antidepresivo que contiene fluoxetina, clorhidrato como principio activo y se presenta bajo la forma de un comprimido dispersable, en la que el principio activo está micronizado y su peso está comprendido entre un ocho y un nueve por ciento (8-9%) del peso total del núcleo de la composición; mientras que la humedad del núcleo de la composición está comprendida entre un tres y un cuatro por cien (3-4%) y el núcleo va recubierto por un revestimiento pelicular que comprende un agente filmógeno hidrosoluble y un agente plastificante, representando este recubrimiento pelicular alrededor de un uno por cien (1%) del peso total del comprimido.Pharmaceutical composition of fluoxetine in a dispersible coated tablet and its manufacturing process, of the type of composition used as an antidepressant containing fluoxetine, hydrochloride as an active ingredient and is presented in the form of a dispersible tablet, in which the active substance is micronized and its weight is comprised between eight and nine percent (8-9%) of the total weight of the core of the composition; while the humidity of the core of the composition is between three and four percent (3-4%) and the core is covered by a film coating comprising a water-soluble film-forming agent and a plasticizing agent, this film coating around one percent (1%) of the total weight of the tablet.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ES200001952A ES2185452B2 (en) | 2000-08-01 | 2000-08-01 | PHARMACEUTICAL COMPOSITION OF FLUOXETINE IN A DISPERSABLE COATED TABLET AND ITS MANUFACTURING PROCESS. |
EP01306472A EP1177788B1 (en) | 2000-08-01 | 2001-07-27 | Pharmaceutical composition of fluoxetin in coated dispersible tablets and process for its manufacture |
DE60131331T DE60131331D1 (en) | 2000-08-01 | 2001-07-27 | Fluoxetine medicaments in the form of coated dispersible tablets and process for its preparation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ES200001952A ES2185452B2 (en) | 2000-08-01 | 2000-08-01 | PHARMACEUTICAL COMPOSITION OF FLUOXETINE IN A DISPERSABLE COATED TABLET AND ITS MANUFACTURING PROCESS. |
Publications (2)
Publication Number | Publication Date |
---|---|
ES2185452A1 ES2185452A1 (en) | 2003-04-16 |
ES2185452B2 true ES2185452B2 (en) | 2004-03-16 |
Family
ID=8494546
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES200001952A Expired - Fee Related ES2185452B2 (en) | 2000-08-01 | 2000-08-01 | PHARMACEUTICAL COMPOSITION OF FLUOXETINE IN A DISPERSABLE COATED TABLET AND ITS MANUFACTURING PROCESS. |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1177788B1 (en) |
DE (1) | DE60131331D1 (en) |
ES (1) | ES2185452B2 (en) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7357891B2 (en) | 2001-10-12 | 2008-04-15 | Monosol Rx, Llc | Process for making an ingestible film |
US20070281003A1 (en) | 2001-10-12 | 2007-12-06 | Fuisz Richard C | Polymer-Based Films and Drug Delivery Systems Made Therefrom |
US8900497B2 (en) | 2001-10-12 | 2014-12-02 | Monosol Rx, Llc | Process for making a film having a substantially uniform distribution of components |
US20190328679A1 (en) | 2001-10-12 | 2019-10-31 | Aquestive Therapeutics, Inc. | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
US10285910B2 (en) | 2001-10-12 | 2019-05-14 | Aquestive Therapeutics, Inc. | Sublingual and buccal film compositions |
US8765167B2 (en) | 2001-10-12 | 2014-07-01 | Monosol Rx, Llc | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
US8900498B2 (en) | 2001-10-12 | 2014-12-02 | Monosol Rx, Llc | Process for manufacturing a resulting multi-layer pharmaceutical film |
US11207805B2 (en) | 2001-10-12 | 2021-12-28 | Aquestive Therapeutics, Inc. | Process for manufacturing a resulting pharmaceutical film |
US8603514B2 (en) | 2002-04-11 | 2013-12-10 | Monosol Rx, Llc | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
US20110033542A1 (en) | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
GB2392385A (en) * | 2002-09-02 | 2004-03-03 | Cipla Ltd | Pharmaceutical preparations comprising a 5HT uptake inhibitor and a homopolymer or copolymer of N-vinyl pyrrolidone |
DE10351448A1 (en) * | 2003-11-04 | 2005-06-09 | Bayer Healthcare Ag | Flavor-containing drug formulations with improved pharmaceutical properties |
EP1993377B1 (en) * | 2006-03-03 | 2012-01-04 | Symrise AG | Pressed agglomerates suitable for consumption having retarded aroma release |
US9149959B2 (en) | 2010-10-22 | 2015-10-06 | Monosol Rx, Llc | Manufacturing of small film strips |
US11273131B2 (en) | 2016-05-05 | 2022-03-15 | Aquestive Therapeutics, Inc. | Pharmaceutical compositions with enhanced permeation |
CN109310646A (en) | 2016-05-05 | 2019-02-05 | 阿奎斯蒂弗医疗股份有限公司 | Enhance the adrenaline composition of delivering |
CN107334742B (en) * | 2017-08-18 | 2020-01-31 | 山东力诺制药有限公司 | fluoxetine hydrochloride dispersible tablet and preparation method thereof |
CN112741819B (en) * | 2020-12-11 | 2022-07-22 | 山西仟源医药集团股份有限公司 | Fluoxetine hydrochloride capsule and preparation method thereof |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ZA753851B (en) * | 1974-08-01 | 1976-05-26 | Ici Ltd | Film coating process |
US4816298A (en) * | 1987-11-27 | 1989-03-28 | The Dow Chemical Company | Method of making a granular, cold water dispersible coating composition |
US4990535A (en) * | 1989-05-03 | 1991-02-05 | Schering Corporation | Pharmaceutical composition comprising loratadine, ibuprofen and pseudoephedrine |
IE61651B1 (en) * | 1990-07-04 | 1994-11-16 | Zambon Spa | Programmed release oral solid pharmaceutical dosage form |
DE4141268A1 (en) * | 1991-12-14 | 1993-06-17 | Merck Patent Gmbh | PHARMACEUTICAL PREPARATION |
US5736159A (en) * | 1995-04-28 | 1998-04-07 | Andrx Pharmaceuticals, Inc. | Controlled release formulation for water insoluble drugs in which a passageway is formed in situ |
US5910319A (en) * | 1997-05-29 | 1999-06-08 | Eli Lilly And Company | Fluoxetine enteric pellets and methods for their preparation and use |
US6096341A (en) * | 1998-10-30 | 2000-08-01 | Pharma Pass Llc | Delayed release tablet of bupropion hydrochloride |
-
2000
- 2000-08-01 ES ES200001952A patent/ES2185452B2/en not_active Expired - Fee Related
-
2001
- 2001-07-27 EP EP01306472A patent/EP1177788B1/en not_active Expired - Lifetime
- 2001-07-27 DE DE60131331T patent/DE60131331D1/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
EP1177788A3 (en) | 2003-01-08 |
DE60131331D1 (en) | 2007-12-27 |
ES2185452A1 (en) | 2003-04-16 |
EP1177788B1 (en) | 2007-11-14 |
EP1177788A2 (en) | 2002-02-06 |
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Legal Events
Date | Code | Title | Description |
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EC2A | Search report published |
Date of ref document: 20030416 Kind code of ref document: A1 |
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FG2A | Definitive protection |
Ref document number: 2185452B2 Country of ref document: ES |
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GC2A | Exploitation certificate registered application with search report |
Effective date: 20050317 |
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FD2A | Announcement of lapse in spain |
Effective date: 20180807 |